Cleared Traditional

K893845 - PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893845 · Medical Associated Services, Inc. · Anesthesiology device
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Oct 1989
Decision
155d
Days
Class 2
Risk

K893845 is an FDA 510(k) clearance for the PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Medical Associated Services, Inc. (Hatfield, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Associated Services, Inc. devices

Submission Details

510(k) Number K893845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1989
Decision Date October 27, 1989
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 139d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.